Interface for a health measurement and monitoring system

ABSTRACT

A testing system and method for providing a testing system includes a user interface having a display for displaying information relating to measurements of health data and an input device for receiving information from a user relating to the health data. Provided in connection with the user interface is an autologging feature adapted to provide the user with user-selectable options on the display. Also provided is a statistical operation adapted to provide the user with enhanced information relating to the measurements of health data. Also provided is at least one indicator for indicating information relating to the number of health data readings that are within a target range, the number of health data readings that are above the target range and the number of health data readings that are below the target range.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of prior U.S. patent application Ser.No. 14/676,975, filed Apr. 2, 2015, now issued as U.S. Pat. No.10,548,537, which is a continuation of prior application Ser. No.12/156,043, filed May 29, 2008, now issued as U.S. Pat. No. 9,022,931,which claims the benefit of and priority to U.S. Provisional ApplicationNos. 61/012,721 and 61/012,718, both filed Dec. 10, 2007, each of whichis hereby incorporated by reference herein in its entirety.

FIELD OF THE INVENTION

The present invention relates generally to systems and methods for thetesting and monitoring of health data. More specifically, the systemsand methods of the present invention provide an interface for displayinginformation regarding the testing and monitoring of health data in amore useful, efficient and intuitive manner.

BACKGROUND OF THE INVENTION

The quantitative determination of analytes in body fluids is of greatimportance in the diagnoses and maintenance of certain physiologicalconditions. For example lactate, cholesterol and bilirubin should bemonitored in certain individuals. In particular, it is important thatindividuals with diabetes frequently check the glucose level in theirbody fluids to regulate the glucose intake in their diets. The resultsof such tests can be used to determine what, if any, insulin or othermedication needs to be administered.

Diagnostic systems, such as blood-glucose systems, include a meter orinstrument used to calculate a glucose value based on a measured output,such as current or color, and the known reactivity of thereagent-sensing element used to perform the test. Blood-glucose systemstypically allow a user to collect a blood sample on a test sensor inwhich the test sensor is located in the meter. The meter measures thereaction between the glucose in the blood sample and a reagent from thetest sensor to determine the blood-glucose concentration in the sample.These systems may store test results in the meter and may display theresults to the user. A keypad or other interactive component may also beprovided on a meter to allow a user to access the test results.

The user interface associated with these systems typically provide theuser with certain features that relate to the testing results. Forexample, in some devices, the user enters information about the user'sactivities, including eating habits, exercise, etc. Typically, the userenters information after the testing has occurred and after the user hasreceived the results. These systems are less effective at encouragingusers to enter such information and in making the entering of theinformation an integral part of the testing process.

In view of the foregoing, there is a need for an approach that providesuser interfaces that are simpler, more intuitive and that become anintegrated part of the testing process. Systems that make the process ofentering information about the user an easier, more intuitive processwill provide the user with a better user experience and will ultimatelygive the user more accurate and meaningful information about his or hercondition. Such systems will encourage users to provide information insuch a manner that it will become a routine part of their testingregimen.

SUMMARY OF THE INVENTION

According to one embodiment, a testing system comprises a user interfaceincluding a display for displaying information relating to measurementsof health data and an input device for receiving information from a userrelating to the health data. The testing system further comprises anautologging feature adapted to provide the user with user-selectableoptions on the display and to prompt the user, during a time periodcorresponding to the amount of time needed to perform the measurements,to input information relating to the health data that corresponds to theappropriate user-selectable option.

According to another embodiment, a method of providing a testing systemcomprises the acts of providing the testing system having a userinterface including a display, receiving health data of the user via ameasurement system, and prompting the user to input user informationthat corresponds to the health data, such that the prompting occurswithin a time period corresponding to the amount of time needed toperform measurements relating to the health data. The method furthercomprises performing the measurements relating to the health data and,during the performing of the measurements, receiving the userinformation that corresponds to the health data via an input device anddisplaying the measurements of the health data on the display.

According to a further embodiment, a testing system comprises a userinterface including a display for displaying information relating tomeasurements of health data and an input device for receiving input fromthe user. The testing system also comprises a statistical operationadapted to provide the user with enhanced information relating to themeasurements of health data. The statistical operation provides the userwith an average value based on a plurality of health data readingsdetermined for a specified time period. The testing system furthercomprises at least one indicator for indicating information relating tothe number of health data readings that are within a target range, thenumber of health data readings that are above the target range and thenumber of health data readings that are below the target range.

In yet another embodiment, a method of providing a testing systemcomprises the acts of providing the testing system having a userinterface including a display for displaying information relating tomeasurements of health data including a plurality of health datareadings, receiving input from the user via the input device andperforming a statistical operation to provide the user with enhancedinformation relating to the plurality of health data readings. Themethod further comprises displaying an output of the statisticaloperation, the output being based on the plurality of health datareadings determined for a specified time period, and displaying at leastone indicator for indicating the number of health data readings that arewithin a target range, the number of health data readings that are abovethe target range and the number of health data readings that are belowthe target range.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A illustrates a testing system having an interface for displayinghealth data.

FIG. 1B illustrates the testing system of FIG. 1A showing a userapplying a fluid sample to a test sensor.

FIG. 1C illustrates information displayed on the user interfacepertaining to an autologging feature.

FIG. 1D illustrates information displayed on the user interfacepertaining to a measurement of one type of health data.

FIG. 2A illustrates information displayed on the user interfacepertaining to a statistical operation performed by the testing system.

FIG. 2B illustrates information displayed on the user interfacepertaining to an averaging feature according to one embodiment.

FIG. 2C illustrates information displayed on the user interfacepertaining to an averaging feature according to another embodiment.

FIG. 2D illustrates information displayed on the user interfacepertaining to an averaging feature according to yet another embodiment.

FIG. 3 illustrates information relating to a user work flow pertainingto an averaging feature according to a further embodiment.

FIG. 4 illustrates a flow diagram pertaining to the autologging feature.

FIG. 5 illustrates a flow diagram pertaining to the averaging feature.

While the invention is susceptible to various modifications andalternative forms, specific embodiments are shown by way of example inthe drawings and are described in detail herein. It should beunderstood, however, that the invention is not intended to be limited tothe particular forms disclosed. Rather, the invention is to cover allmodifications, equivalents, and alternatives falling within the spiritand scope of the invention.

DESCRIPTION OF ILLUSTRATED EMBODIMENTS

Testing systems of the present invention provide information relating tohealth data. This health data may be collected, measured or input by auser. One example of such health data is an analyte concentration in abody fluid sample, such as glucose in a blood sample. Other types ofhealth data may include heart rate measurements, blood pressuremeasurements, body temperature measurements, breathing measurements forchronic obstructive pulmonary disease (COPD) analysis, weightmeasurements for analyzing furosemide (LASIX®) use, and the like. Formeasurements that do not require analyte testing, the testing device 10may monitor and analyze these types of health data and provide a userwith the relevant information about the user's medical condition.Wherein the following description refers mainly to testing of analytesin fluid samples, it will be appreciated that other types of health datamay be used with aspects of the present invention.

In some embodiments, a testing device as described herein may beemployed in a larger health data management system that connects thetesting device with other external processing devices, health caredevices, and/or other devices/systems. The testing device may takeadvantage of the processing and user interface capabilities of suchdevices. For example, some functionalities may be better viewed onexternal processing devices if the size of the user interface on thetesting device is too compact. Meanwhile, the health care devices maytake advantage of the processing and user interface capabilities of thetesting device. The interface between the testing device and theexternal devices may employ a wired communication protocol, such as theuniversal serial bus (USB) standard, or a wireless communicationprotocol, such as Bluetooth® technology.

For example, the testing device may be a blood glucose meter thatinterfaces with a processing device, such as a conventional personalcomputer (PC). Although the blood glucose meter may include advanceddata processing and display features as described herein, users of theblood glucose meter may access more sophisticated analyses andpresentations of blood glucose test data by connecting the blood glucosemeter to a processing device that executes data-management software. Forexample, the software may be a product similar to WINGLUCOFACTS®Diabetes Management Software available from Bayer HealthCare LLC(Tarrytown, N.Y.). In another example, the testing device may be a bloodglucose meter that interfaces with a health care device, such as a heartrate monitor, that transmits health data that can be combined with thedata collected by the blood glucose meter itself.

Referring to FIG. 1A, one embodiment of a testing device 10 and a testsensor 12 is illustrated. The test sensor 12 is configured to receive afluid sample which is analyzed using the testing device 10. Analytesthat may be analyzed include glucose, lipid profiles (e.g., cholesterol,triglycerides, LDL and HDL), microalbumin, hemoglobin Mc, fructose,lactate, or bilirubin. The analytes may be in, for example, a wholeblood sample, a blood serum sample, a blood plasma sample, other bodyfluids like ISF (interstitial fluid) and urine, and non-body fluids.

As shown in FIG. 1B, the test sensor 12 includes a fluid-receiving area14 for receiving a fluid sample. For example, a user may employ a lancetor a lancing device (not shown) to pierce a finger or other area of thebody to produce the fluid sample at the skin surface. The user may thencollect this fluid sample by placing the test sensor 12 into contactwith the sample. The fluid-receiving area 14 may contain a reagent whichreacts with the sample to indicate the concentration of an analyte inthe sample.

In other embodiments, samples may be collected via a continuous glucosemonitor (CGM) probe that is worn by the user and which collects samplesof body fluid subcutaneously. Furthermore, different types of body-wornsensors and/or transmitters are contemplated as being usable with thepresent invention. For example, watches, arm bands, patches, earpieces,and other telemetry-based devices may be used to collect health data inconnection with the embodiments disclosed herein. Such devices may besmaller, lighter and less invasive than traditional devices used forcollecting health data.

The test sensor 12 may be an electrochemical test sensor. Anelectrochemical test sensor typically includes a plurality of electrodesand a fluid-receiving area that contains an enzyme. The fluid-receivingarea includes a reagent for converting an analyte of interest (e.g.,glucose) in a fluid sample (e.g., blood) into a chemical species that iselectrochemically measurable, in terms of the electrical current itproduces, by the components of the electrode pattern. The reagenttypically contains an enzyme such as, for example, glucose oxidase,which reacts with the analyte and with an electron acceptor such as aferricyanide salt to produce an electrochemically measurable speciesthat can be detected by the electrodes. It is contemplated that otherenzymes may be used to react with glucose such as glucose dehydrogenase.In general, the enzyme is selected to react with the desired analyte oranalytes to be tested so as to assist in determining an analyteconcentration of a fluid sample. If the concentration of another analyteis to be determined, an appropriate enzyme is selected to react with theanalyte.

Alternatively, the test sensor 12 may be an optical test sensor. Opticaltest sensor systems may use techniques such as, for example,transmission spectroscopy, diffuse reflectance, or fluorescencespectroscopy for measuring the analyte concentration. An indicatorreagent system and an analyte in a fluid sample are reacted to produce achromatic reaction, as the reaction between the reagent and analytecauses the sample to change color. The degree of color change isindicative of the analyte concentration in the fluid. The color changeof the sample is evaluated to measure the absorbance level of thetransmitted light.

Some commercially available test sensors that may be used by theembodiments described herein include those that are availablecommercially from Bayer HealthCare LLC (Tarrytown, N.Y.). These testsensors include, but are not limited to, those used in the Ascensia®CONTOUR® blood glucose monitoring system, the Ascensia® BREEZE® andBREEZE®2 blood glucose monitoring system, and the Ascensia® Elite® andElite® XL blood glucose monitoring system. It is contemplated that othertest sensors, in addition to the ones listed above, may be incorporatedinto the methods and systems of the present invention.

As illustrated in FIG. 1B, the testing device 10 receives and engagesthe test sensor 12. The testing device 10 includes a reaction-detectionsystem for measuring the concentration of analyte for the samplecollected by the test sensor 12. As described above, thereaction-detection system may include contacts for the electrodes todetect the electrochemical reaction for an electrochemical test sensor.Alternatively, the reaction-detection system may include an opticaldetector to detect the chromatic reaction for an optical test sensor. Tocalculate the actual concentration of analyte from the electrochemicalor chromatic reaction measured by the reaction-detection system and togenerally control the procedure for testing the sample, the testingdevice 10 employs at least one processor (not shown), which typicallyexecutes programmed instructions according to a measurement algorithm.Data processed by the processor may be stored in a memory element.

The testing device 10 of FIG. 1B includes a user interface 20, whichincludes a display 22 and a user input device 24. The display 22typically displays information regarding the test results, the testingprocedure and/or information in response to signals input by the user,including text and images. The display 22 may be a graphic liquidcrystal display (LCD), an organic light-emitting diode (OLED), segmentLCD, or the like. The user input device 24 allows the user to interactwith the testing device 10 and may include pushbuttons, soft keys, ascroll wheel, touch screen elements, or any combination thereof.

It is contemplated that the user interface 20 may provide ahigh-resolution, rich viewing display 22, which may present both staticand moving text and images to the user. However, other types ofdisplays, including, for example, lower resolution, monochromatic LCDdisplays, may be employed. In general, a range of display types, from alow-cost basic display to a fully functional display, may be employed.The display 22 may be of any suitable size. In some cases, the display22 may cover one entire side of the testing device 10. Moreover, thedisplay 22 may include a touchscreen. In addition, the user interface 20may provide advanced graphical user display and audio capabilitiesavailable directly on the testing device 10 or via a communicationsinterface with the testing device 10.

As described previously, the testing device 10 employs at least oneprocessor that typically executes programmed instructions, as well asthe user interface 20, which includes the display 22 to presentinformation to the user, and input devices 24, such as pushbuttons, softkeys, a scroll wheel, touch screen elements, or any combination thereof,to enable interaction with the user. With such components, the testingdevice 10 generally controls the procedure for testing the sample andcalculating the test results and for providing a plurality of userfeatures. Certain of the user features of the testing device 10 may beavailable to the user via a hierarchical menu. The user is allowed tonavigate through the hierarchical menu to access certain features of thetesting device 10 that are described in more detail below. In someembodiments, the hierarchical menu has no more than four levels toprovide quick and convenient access to the features of the device. Forexample, a user may operate a set of soft keys that corresponds to itemsin the hierarchical menu. In one embodiment, the testing device 10provides three soft keys that are not dedicated to specific functions.Rather, the display 22 shows one set of three menu items and each of thesoft keys is assigned to one of the menu items. Operating a soft keyselects the corresponding menu item and either navigates the user toanother level in the hierarchical menu or executes a particularfunction. Because the menu items are dynamically assigned to the softkeys, the user interface 20 does not require a separate key for eachpossible function, so many different functions are available even in acompact user interface 20. Further examples of such soft keys aredescribed in detail herein below.

In some embodiments, to provide an easier and more intuitive process ofentering information, the user interface 20 may prompt the user to inputinformation or instructions into the testing device 10 relating to oneor more features. More specifically, the user may be asked to respond tosimple prompts or make menu selections to guide the user duringoperation of the testing device 10. One example of the user beingprompted is shown in FIG. 1B in relation to an autologging feature. Withthis particular feature, once the test sensor 12 is inserted in thetesting device 10, the user interface 20 provides instructions to theuser to “APPLY BLOOD TO STRIP.” The user interface 20 of FIG. 1B alsopictorially displays a drip of blood with an arrow pointing to a testsensor to further guide the user.

Upon applying the blood to the strip, the user may be prompted to enterinformation into the testing device 10, as illustrated in FIG. 1C.Specifically, the user is prompted to “ADD COMMENT” via the userinterface 20. To enter the requested information, the user may selectfrom one or more user-selectable options displayed on the user interface20. The user-selectable options may displayed adjacent to one or moreinput devices 24, such as soft keys, for receiving the user's input. Inanother example, the input devices 24 may also be used to retrieveinformation, such as test results, and to present the information on thedisplay 12.

As noted above, FIGS. 1B and 1C illustrate certain prompts on the userinterface 20 associated with an autologging feature, in particular for adiabetes-management system. These prompts immediately follow theapplication of blood onto the test sensor 12. Specifically, the userinterface 20 prompts the user to press an input device 24 to select oneof three user-selectable options 30 that correspond to the fluid samplebeing tested. Such information may be provided by inputting a single“click” of one of the soft keys on the input device 24. The particularuser-selectable options associated with the autologging feature may beindicators, such as meal markers, that indicate when the fluid samplewas taken in relation to when a meal has or has not been eaten. Forexample, one set of meal markers may include a “before food” marker(32), an “after food” marker (34) and a “skip” or “none” marker (36).

In the embodiment shown in FIG. 1C, the input device 24 includes threesoft keys 42, 44, 46 which are assigned to each of the threeuser-selectable options 30. After a fluid sample is applied to the testsensor 12, a user is prompted during a certain time period to make aselection of one of the user-selectable options. Advantageously, thetime period for receiving the user's selection may correspond to thetime that it takes to perform the testing and calculations necessary todisplay the testing result. In some embodiments, the time period may beabout 5 seconds. In other embodiments, the time period may be more orless than 5 seconds (i.e., 3 seconds, 10 seconds) and may depend on thetype of test being performed.

This timing is an important feature as it allows for an opportunity toprompt the user to enter certain information, i.e., pre- and post-mealmarkers. Having the user input information relating to meals or otherpertinent information occupies the user while he or she is waiting forthe testing results. Furthermore, employing a testing system that takes,for example, 5 seconds to test the fluid sample generally will provide ahigher level of accuracy than systems that may provide results in lessthan 5 seconds. Thus, it is desirable to have a testing system thatprovides sufficient time for the testing to occur and that also usesthat time to gather additional beneficial information.

Ultimately, the information that is provided by the user may becategorized so that an evaluation of the data yields a more usefulanalysis for the user. Categorizing health data with meal markers, forexample, helps the user to gain a better understanding of what valuesare being averaged and makes the data more actionable. In someembodiments, the categorization of information may be customized fordifferent user groups, such as children or the elderly. Suchcategorization may be useful, for example, when taking averages of testresults as certain averages, without more specific indicators, can maskinformation that may be useful in treating a disease.

After a selection is made by pressing one of the soft keys 42, 44, 46, atest result 50 is presented to the user, as shown in FIG. 1D. In thisexample, the test result 50 comprises a number indicative of a glucoseconcentration reading, along with the concentration units 52 and thedate 54 and time 56. In this example, a concentration reading of 127mg/dL is displayed, along with additional information pertaining to themeal marker. In some embodiments, the user can use a scroll function 60to scroll back and forth among measurements performed by the testingdevice 10 to view prior testing results. This scroll function 60 isaligned with at least one soft key. Such prior testing results may beincluded in a log book feature that allows the user to identify dates,times and readings of prior concentration values.

FIG. 4 provides a flow diagram illustrating generally the steps forentering information relating to the autologging feature and receivingthe output via the user interface 20. Generally, upon receiving healthdata from the user, the testing of the health data is initiated and thetesting is performed during a specified time period. The user isprompted to enter information relating to the health data via the userinterface during the specified time period corresponding to the testingof health data, e.g., the user is prompted to add comments during a fivesecond testing time. The user then inputs information relating to thehealth data via the user interface, e.g., by selecting a pre-meal orpost-meal marker. Once the testing of the health data is completed, themeasurements are displayed via the user interface. Additionally, theinformation relating to the health data that is input by the user mayalso be displayed, i.e., “before food” or “after food.”

A primary advantage of the autologging feature is that it allows theuser a way to record his or her readings as either pre-meal or post-mealdata. The segregation of readings into pre/post meal categories allowsusers to better analyze the effects of food intake upon their bloodglucose readings. In some embodiments, graphical elements 37, 38 can beused to make the selection process easier and to encourage users to marktheir readings as pre- or post-meal during the testing routine. In thisexample, the pre-meal marker is identified with a whole apple and thepost-meal marker is identified with an apple core; however, variousgraphical elements and/or wording may be used in connection with theautologging feature. In effect, the autologging feature automates thetask of keeping a paper logbook by most individual with diabetes. Theautologging feature also helps healthcare providers to draw theirpatients' attention to how food affects blood glucose readings.

In some circumstances where there is an immediate need for the testingresults, it may be desirable to bypass the autologging feature in orderto obtain the information relating to the analyte concentration readingand other measurements of health data without requiring that the userselect one of the user-selectable options. This may be important wherethe user is having, for example, a hypoglycemic event that makes morecritical the amount of time that is necessary to obtain the results fromthe testing device 10. The user may opt to bypass the autologgingfeature by selecting “skip” at the autologging feature, causing thetesting results to be promptly displayed. Alternatively, the user maysimply press a button that provides the results before the autologgingfeature is initiated. In some embodiments, the autologging feature maybe initiated after the critical health data is displayed. Thus, the usermay be given three opportunities to enter information pertaining to anautologging feature: during testing, after testing or after the “bypass”condition.

As mentioned above, other types of health data may be used with thepresent invention to provide important information to the user regardingthe user's medical condition. Health data, such as heart ratemeasurements, blood pressure measurements, body temperaturemeasurements, breathing measurements for COPD analysis, weightmeasurements for analyzing furosemide (LASIX®) use, and the like may bemonitored, analyzed and reported to the user via the user interface 20.For example, the autologging feature may be used to provide a user withimportant details relating to a user's heart rate as it relates to oneor more external factors, such as when the user recently ate, slept,exercised, etc.

Other features providing different types of information can be displayedon a user interface 120. One such feature is shown in FIGS. 2A-2D, whichdepict a testing device 110 having a user interface 120 and display 122.According to this feature, a user is allowed to select, for example, adesired average reading from a list of selectable averages. For example,FIG. 2A illustrates a user interface 120 that provides a user with theoption to select a “7-day” average 142, a “14-day” average 144 and a“30-day” average 146. The user interface 120 also provides informationregarding target ranges for certain categories of readings, for example,a pre-meal target range 150 and a post-meal target range 152. Theseranges 150, 152 may be default values or may be dependent on informationinput by the user. Thus, a user may be able to select from severalaveraging options: 7-day pre-meal, 7-day post-meal, 7-day overallaverage; 14-day pre-meal, 14-day post-meal, 14-day overall average; and30-day pre-meal, 30-day post-meal and 30-day overall average. In someembodiments, a default average may include only the 14-day averages, forexample. However, through connection to an external device, such as, forexample, a PC, the user may tailor the averaging functionality viasoftware embedded on the PC. The user may select other default settingsand/or add additional functionalities relating to the autologging andaveraging features.

FIGS. 2B-2D illustrate the user interface 120 after a user has selectedan average reading to be displayed. For example, when a user selects the“7 day” average 142, the user interface 120 displays the value 160associated with the “7 day” average, e.g., 127 mg/dL, as shown in FIG.2B. When a user selects the “14 day” average 144, the user interface 120displays the value 170 associated with the “14 day” average, e.g., 155mg/dL, as shown in FIG. 2C. When a user selects the “30 day” average146, the user interface 120 displays the value 180 associated with the“30 day” average, e.g., 168 mg/dL. The user interface 120 may alsoindicate which of the readings is being displayed, i.e., “7 DayResults,” to remind the user which averaging function the user selected.

In addition to displaying an average reading, the illustratedembodiments shown in FIGS. 2A-2D also reveal important information aboutthe components of the average reading, e.g., “above,” “below” and “intarget.” This additional useful information may be displayed to the userto indicate the number of readings that fall within the target range164, 174, 184, the number of readings that fall above the target range162, 172, 182 and the number of readings that fall below the targetrange, 166, 176, 186. Also, the total number of readings 168, 178, 188that are used to provide the average value may be displayed for each ofthe specific averaging readings.

In some embodiments, different colors may be associated and displayedwith such a feature to assist in interpreting the testing results. As anexample, red may be used to indicate readings that are below the targetrange, yellow may be used to indicate readings above the target range,and green may be used to indicate readings which are in the targetrange. In general, red may be used for a reading below the target range,because hypoglycemic events indicated by such a reading may presentconditions which are more dangerous for a user. Furthermore, symbols maybe used to pictorially represent the above, below and target ranges. Forexample, as shown in FIG. 3, an “up” arrow sign 90, a check mark 92 anda “down” arrow sign 94 may be placed next to a number of readings torepresent pictorially the number of readings above, below and withintarget ranges, respectively. Such symbols may make it easier for user toidentify the different categories and to understand the relationshipsbetween the components that make up the average value. FIG. 3 alsodepicts an example of the work flow of information relating to a menu offeatures that may be accessed by a user. For example, a user may selecta “Trends” feature, which allows the user to scroll up and down betweenaverages, such as pre-meal averages and post-meal averages. As notedabove, the user can use the scroll function 60 (as depicted by the upand down triangles) to scroll between different types of averages, orother statistical operations, and between other types of informationthat may be provided in the Logbook, Trends and Setup functions.

This feature, which indicates the number of readings within and outsideof a target range, provides useful information to the user, as well as aphysician or nurse, to better reveal the trend of readings and to spotpotentially troubling readings which a user may want to address. Inaddition, such a feature allows the user, physician or nurse to identifyoutlier data in testing results based on testing collected over severaldays, i.e., 7, 14 or 30 days. This information is presented in anintuitive and easily-understood manner so that a user can appreciatesuch results and make changes in the user's diet, exercise program,etc., which can help to reduce or eliminate the number and occurrence ofreadings outside of the target range.

FIG. 5 provides a flow diagram illustrating generally the steps forentering information for performing a statistical operation and forreceiving the output via the user interface 20. Generally, uponreceiving health data from a user, the use inputs information via theuser interface (e.g., selection of 7-day, 14-day or 30-day average).Depending on the information received from the user, a statisticaloperation, e.g., average, standard deviation, etc., is performedrelating to the health data. The output of the statistical operation,e.g., a 7-day average concentration reading, is displayed via the userinterface. Additional information or indicators may also be displayed toindicate enhanced information relating to the health data, e.g., thenumber of readings within, above or below the target range.

The user interface 120 allows users to further investigate the averagereading and view the memory for more specific readings composing theaverage readings contained in a log book function. This may be achievedby scroll buttons or by selecting from a menu of options. For example,the user may opt to display the average value and target range forpost-meal readings 150 or for pre-meal readings 152. This has the addedbenefit of further focusing a user's attention on eating habits and itsrelationship to the glucose concentration readings. This also allows theuser to identify which readings contribute more to the number ofreadings outside of the target range and to allow the user to makeadjustments to their meal routine. In general, the aspects of theembodiments described herein make the process of entering informationabout health data an easier, more intuitive process and provide the userwith a better user experience. Furthermore, such embodiments willultimately give the user more accurate and meaningful information abouthis or her condition and will encourage users to provide information insuch a manner that it will become a routine part of their testingregimen.

In addition to the averaging of readings, other embodiments may alsoperform other types of statistical operations in addition to, or in lieuof, the averaging feature. For example, other types of statisticaloperations may include median values, mode values, standard deviations,confidence intervals, and the like. Furthermore, as mentioned above withrespect to the autologging feature, other types of health data may beused with the statistical operations to provide important information tothe user regarding a user's medical condition. Health data, such asheart rate, blood pressure, body temperature, breathing measurements,weight measurements and the like may be monitored, analyzed and reportedto the user via the user interface 20, 120. For example, the statisticaloperations may be used to provide a user with important details relatingto a user's heart rate based on values taken over a period of 7, 14 or30 days. This allows the user to view such health data in the context ofother readings taken over a particular time frame.

Other types of information may be entered by a user to add additionalnotes regarding the health data. For example, a user may be able toenter such notes as “gym day,” “sick,” “stress,” “activity,” “don't feelright,” “traveling” and the like, to further identify the factors thatmay affect the measurement of the health data. Such labeling providesimportant information about lifestyle factors that enhance the value ofthe data to the users. Predefined notes may be provided for convenience,or the user may be able to customize notes through the user interface20, 120. In other embodiments, the user may create notes through aseparate software system and upload the notes to the testing device 10through a communication interface.

In general, the user interface 20, 120 may present different informationaccording to a variety of features to facilitate operation of thetesting device 10. For example, the user interface 20, 120 may provide apower status indicator which shows the amount of power remaining in arechargeable battery in the testing device 10. In addition, the userinterface 20, 120 may display a countdown, rather than issuing an alarm,for testing times and may display a second clock for traveling. In otherembodiments, the user interface 20, 120 may display a question mark forrequested or missing information. Furthermore, the size of the displayeddata may be modified depending on the type of data displayed and wherein the testing process the data is being displayed. For example, thefont size of a concentration reading may change to provide alarger-sized value to display to the user immediately after the testingis performed and then may modify the font size (i.e., make it smaller tofit on the display with additional information) of the value shortlythereafter. The changing of the size of the displayed data may alsosignal processing or logging of data.

As described previously, testing devices according to aspects of thepresent invention may include interfaces to connect to external systemsor devices. The ability to communicate with external systems or devicesmay allow the testing device to download data and/or software. In someembodiments, for example, the testing device 10 may be field upgradeableto provide updates or patches to software on the testing device 10. Theuser interface 20, 120 may also be employed to facilitate the process ofdownloading data, such as field upgrades. For example, the userinterface 20, 120 may communicate the availability of new or upgradedfeatures via an icon on the display, when an external system signals theavailability to the testing device 10. The user may then initiate, viathe user interface, the transfer of the new or upgraded features. Insome cases, the user may manage or control the transfer of such featuresby, for example, selecting particular features from a menu of featuresavailable for download.

The text and images provided on the user interface 20, 120 provideelements that enhance a user's experience with the device. In someembodiments, the display 22, 122 may have customizable attributes. Forexample, the display 22, 122 may have a customizable background,wallpaper, and/or animated screensaver. In some embodiments, users cancustomize the appearance of the user interface 20, 120 by installingcustom pictures to display on the screen or by downloading displaylayouts made available by a manufacturer or an authorized third party.

In addition, user interfaces 20, 120 may allow information to becommunicated to and from the user via audio signals. For example,input/output interfaces may include a speech synthesizer, MP3 playback,or the like, for communicating audio information to a user.Additionally, the input/output interfaces may also include a speechrecognition mechanism to receive audio information from a user. In someembodiments, an audio interface (not shown) may be customized to useselected sounds, beeps, rings, tones, verbal messages, etc.

Furthermore, the user interfaces 20, 120 may provide access to varioustypes of audio-visual content such as those associated with a PDA, smartcellular phone, etc. For example, a web browser available on the userinterface 20, 120 may provide a further interface to functionality andfeatures available through a connection to the Internet provided by acommunication interface on the testing device 10. Additional userinterface functionality may be provided by allowing e-mail functionalityor text messaging functionality. Other user-selected audio-visualcontent may include music, movies, videos, video games, and the like.

In general, the user interface 20, 120 may be customizable toaccommodate a user's personal preferences. For example, in someembodiments, the user interface 20, 120 may communicate in manylanguages. In one aspect, the data required to provide multi-languagecapability does not have to be stored locally, as users may downloadlanguage files, via the communication interface, to customize theoperation of their systems. Also, in another example, a flippable userinterface may be provided on the testing device to accommodate righthand users and left hand users. The user interface may be digitallyreoriented via a touch screen.

In yet other embodiments, as a convenience to the user, the last screenthat was used by the user can be immediately displayed upon reactivatingthe testing device 10, 110. In other words, the testing device 10, 110may store the state of the display, including prior information input bythe user, so that user does not have to navigate through a menu ofoptions. As described above, a testing device as described herein may beemployed in a health management system that connects the testing devicewith an external processing device that executes a data-managementsoftware. Moreover, the testing device may take advantage of the userinterface capabilities of the processing device. As such. the ability torestore the state of the testing device 10, 110 can also be communicatedto external processing device so that the data-management softwarestarts at the most recent screen or function accessed by the user. Forexample, if the user most recently accessed a log book functionality onthe testing device, the data-management software will automaticallystart at a corresponding log book function.

While the invention is susceptible to various modifications andalternative forms, specific embodiments and methods thereof have beenshown by way of example in the drawings and are described in detailherein. It should be understood, however, that it is not intended tolimit the invention to the particular forms or methods disclosed, but,to the contrary, the intention is to cover all modifications,equivalents and alternatives falling within the spirit and scope of theinvention.

What is claimed is:
 1. A testing system for measuring a concentration ofanalyte in a body fluid sample, comprising: a housing having a portconfigured to receive a test sensor therein in a generally horizontaldirection, the port being disposed along a horizontal axis of thehousing; a display configured to display measurements of the analyteconcentration of the body fluid; a plurality of soft keys for receivinginput from the user and being disposed adjacent to the display, theplurality of soft keys being dynamically assigned to user-selectableoptions displayed on the display; and at least one processor configuredto analyze the measurements of the analyte concentration of the bodyfluid, wherein the at least one processor is configured to cause thedisplay to display a plurality of user-selectable statisticaloperations, wherein the at least one processor is further configured tocause the display to display each of the plurality of user-selectablestatistical operations in a single horizontal line of text in arespective segment of the display, each respective segment extending inthe generally horizontal direction and being parallel to the horizontalaxis of the meter, and wherein each soft key adjacent to the display isaligned with a respective one of the plurality of user-selectablestatistical operations displayed on the display.
 2. The testing systemof claim 1, wherein each soft key adjacent to the display is assigned tothe respective one of the plurality of user-selectable statisticaloperations.
 3. The testing system of claim 1, wherein each soft keyadjacent to the display is operable to cause the display to display thestatistical output associated with the respective one of the pluralityof user-selectable statistical operations.
 4. The testing system ofclaim 1, wherein each soft key is further operable to cause the displayto display components of the statistical output associated with therespective one of the plurality of user-selectable statisticaloperations.
 5. The testing system of claim 1, wherein the plurality ofuser-selectable statistical options includes a seven-day average, afourteen-day average, and a thirty-day average.
 6. The testing system ofclaim 1, wherein the processor is further configured to simultaneouslydisplay, responsive to one of the plurality of user-selectablestatistical operations being selected, (i) the statistical outputassociated with the selected one of the plurality of user-selectablestatistical operations and (ii) a plurality of components of thestatistical output associated with the selected one of the plurality ofuser-selectable statistical operations.
 7. The testing system of claim6, wherein each of the plurality of components of the statistical outputis aligned with a respective one of the plurality of soft keys.
 8. Thetesting system of claim 1, further comprising a continuous glucosemonitor probe configured to collect the body fluid sample.
 9. Thetesting system of claim 1, wherein the at least one processor is furtherconfigured to cause the display to rotate so as to correspond todifferent orientations of the housing.
 10. The testing system of claim9, wherein the rotation of the display allows the testing system toaccommodate right hand users and left hand users.
 11. The testing systemof claim 9, wherein the display is a touch screen and the rotation ofthe display includes digitally rotating the information displayedthereon.
 12. The testing system of claim 9, responsive to the displaybeing in a first orientation, the display is configured to display afirst one of the plurality of user-selectable statistical operations ina first segment of the display and a last one of the plurality ofuser-selectable statistical operations in a last segment of the display,and responsive to the housing rotating from the first orientation to asecond orientation, the display is configured to display the first oneof the plurality of user-selectable statistical operations in the lastsegment of the display and the last one of the plurality ofuser-selectable statistical operations in the first segment of thedisplay.
 13. The testing system of claim 12, responsive to the displaybeing in the first orientation, the display is configured to display acentral one of the plurality of user-selectable statistical operationsin a central segment of the display, and responsive to the housingrotating from the first orientation to the second orientation, thedisplay is configured to display the central one of the plurality ofuser-selectable statistical operations in the central segment of thedisplay.